ACTRN12618001158257已完成2 期
A Pilot, Randomised Controlled Trial of Midodrine to reduce the duration of blood pressure supporting medicines as an Adjunctive Vasopressor sparing approach for Fluid-Refractory Hypotension in Intensive Care Patients
Austin Hospital0 个研究点目标入组 62 人开始时间: 2018年7月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
The addition of midodrine therapy was feasible with acceptable compliance, duration of therapy, and safety profile. However, at the chosen dose, there was no evidence of physiological or clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Admission to the Austin Hospital ICU
- •Age 18 years or greater
- •Refractory hypotension (as defined above), requiring treatment with a single intravenous vasopressor at low dose (as defined above)
排除标准
- •Clinical haemodynamic instability, including high vasopressor requirement (i.e. noradrenaline > 10 mcg/min; metaraminol > 100 mcg/min)
- •Severe shock state, as evidenced by a lactate > 4 mmol/L or multiple vasopressor infusions
- •Renal failure as evidenced by a KDIGO Stage 1 Acute Kidney Injury, whereby creatinine is 1.5-1.9 times baseline OR urine output is <0.5 mL/kg/hr for 6-12 hours
- •Alternate treatable cause for refractory hypotension (i.e. bleeding, hypovolemic shock, cardiogenic shock, obstructive shock)
- •Patients with liver failure, severe heart disease, pregnancy, thyrotoxicosis
- •Acute brain pathology in which the treating clinician deems it inadvisable to enrol the patient, for example subarachnoid haemorrhage or those with current cerebral perfusion pressure (CPP) therapies in place
- •Bradycardia, heart rate less than 50 bpm
- •Those being feed via a jejunal tube
- •Those with no enteral route available
研究者
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